Could Your Quality Systems Protect You in a Court of Law?

Could Your Quality Systems Protect You in a Court of Law?

Mark Crawford

Quality system management and documentation contain a wealth of information (or lack of) that can be used by a regulatory agency like the FDA or a plaintiff in a lawsuit to determine if the company is in compliance with federal regulations or its own internal quality management procedures. Failure to meet these requirements can be highly damaging to a company in litigation.

“Quality manuals and quality system documents are intended to guide the operation of a company’s quality management system, says James Kolka, president of Kolka & Associates in Atlanta and an international legal consultant in regulatory affairs. “Quality system documents are neither intended nor constructed to provide evidence of a company’s concern for patient safety and product safety. If a company wants to prove it cares about patient safety and make safe products, it must build documentation to prove that point.”

Areas of product liability litigation

The three major areas of product liability litigation—design, manufacturing, and post-market surveillance—are specifically addressed by clauses in each regulatory quality management system.

For example, to design a medical device using FDA’s Quality System Regulation, a company that wants to manufacture Class III, Class II, and certain Class I medical devices must follow 21 CFR 820.30 Design Controls.

“This means that there should be documents and records describing the stages of design development: 820.30 (b) design and development planning, (c) design input, (d) design output, (e) design review, (f) design verification, (g) design validation, (h) design transfer, (i) design changes, and (j) design history file,” Kolka states. “This means records should exist documenting each of those stages, including risk analyses where and as needed. If records don’t exist, the device was not designed in accordance with FDA regulations.”

This knowledge is available to plaintiffs’ attorneys in the event of a product liability lawsuit. Manufacturing a medical device follows its own set of QSR regulatory clauses. To be effective and not be blindsided by plaintiff’s allegations citing quality system breakdowns, corporate counsel must understand regulatory quality management systems in depth and strengthen protocols if necessary to create a stronger legal position.

On his blog at, Kolka cites a private “in-depth” litigation study conducted by a medical device insurance company of its litigation history. “Since virtually all of their lawsuits have been settled out of court, there is no public record of mistakes to guide other medical device manufacturers, thereby allowing them to repeat the same mistakes over and over,” says Kolka.

The litigation study revealed several key findings regarding weaknesses of medical device manufacturers in product liability lawsuits:

  • Several medical device manufacturers constructed quality management systems to satisfy FDA and EU medical device regulatory requirements, but contained no documented methods, processes or procedures for communicating product safety concerns and/or incorporating those concerns into their business processes, thereby demonstrating no commitment to product safety.
  • The study found a lack of internal processes and procedures in companies’ QM systems for escalating product safety concerns and a review of those concerns, as well as a lack of any kind of cross-functional committee to deal with product safety issues. Plaintiffs’ attorneys alleged that this demonstrated a lack of due care and concern for product and patient safety.
  • The study found several instances of biotech firms failing to protect their documentation by asserting that attorney-client privilege prevented plaintiffs from examining their documentation during discovery, which assertion was not accepted by the court.
  • The study found misconceptions by management of medical device manufacturers that compliance with FDA’s quality system regulations was enough to prevent product liability claims.
  • The study found that management frequently continued to underestimate the risk of product liability litigation to the success and/or survival of their business.
  • The study found that design research documents and agreements often contain hidden product liability exposures—the agreements were not reviewed by legal counsel familiar with clinical research or by insurers or brokers reviewing coverage limits and indemnification clauses.
  • The study found a lack of qualified in-house personnel available to integrate product liability avoidance principles into the firm’s quality management system and establish an infrastructure for product safety, resulting in product liability post-production legal defense problems.
  • The study found that company postproduction corrective and preventive actions were deemed to be inadequate for the degree of risk presented by individual complaint investigations resulting in both FDA regulatory actions and product liability lawsuits.

These are just some of the problems uncovered by the litigation study.

“The actual list is quite long and quite disturbing,” says Kolka. “The lack of training for product liability exposure is extraordinary. Virtually no firms conduct product liability audits or product safety audits of their operations. The assumption appears to be that compliance with FDA and EU regulations is sufficient. From my experience, quality managers do not see legal issues as their responsibility and therefore will pass them off to regulatory managers, corporate counsel and management. In turn regulatory managers do not focus on product liability exposure.”

Because the focus on product safety and patient safety tends to be inadequate, records are poorly maintained, and the wording of documents pays no attention to the legal consequences of what is said, “it appears that product liability lawsuits will continue to plague medical device manufacturers,” Kolka concludes. “There are steps that can be taken with training personnel to conduct product liability audits, product safety audits, and learn how to write documents so that the words don’t become minefields for litigation.”

Contact Kolka at or

Pilgrim Quality Solutions

Pilgrim pioneered quality management software more than 25 years ago for regulated enterprises that needed a better way to deliver, track and oversee quality-related activities.